Health Condition 1: D561- Beta thalassemia
Conditions
Interventions
Intervention1: Cap Hydroxyurea 500 mg: Dose of 10â??20 mg per kg orally daily for 6 months (For participants with less than 50 kg receive one 500 mg capsule, while the participants having more than 50
Sponsors
Multidisciplinary Research Unit MRU
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 6 years and above. Patients with confirmed genotypes of homozygous/ compound heterozygous β-thalassaemia major or HbE β-thalassaemia. Patients who required more than eight blood transfusions during the preceding 12 months.
Exclusion criteria
Exclusion criteria: Sickle β-thalassaemia Coexisting chronic liver disease Coexisting chronic kidney disease Coexisting viral hepatitis Patients with contraindications for hydroxyurea (e.g., hypersensitivity, bone marrow depression, pregnancy and lactation) Patients who are expecting to get pregnant during the next 12 months Patients who have undergone bone marrow transplantation Patients on immunosuppressant therapy Baseline serum ferritin >5000 ng/mL Baseline white cell count Baseline platelet count Patients who were started on regular transfusions for a predetermined limited period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction in transfusion requirement as an outcome measure.Timepoint: Follow up monthly during the 6 months of treatment and post treatment follow up for another 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in iron overload as assessed by serial serum Ferritin valuesTimepoint: The test will be done every 3 monthly. | — |
Countries
India
Contacts
Public ContactVarun Kaul
Gobind Singh Medical College and Hospital Faridkot
Outcome results
None listed